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Dialectical Behavior Therapy (DBT) for Adolescents With Bipolar Disorder (DBT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02003690
Recruitment Status : Active, not recruiting
First Posted : December 6, 2013
Last Update Posted : March 24, 2020
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Tina R Goldstein, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE December 2, 2013
First Posted Date  ICMJE December 6, 2013
Last Update Posted Date March 24, 2020
Actual Study Start Date  ICMJE February 2014
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2013)
  • Suicidal events [ Time Frame: Over two year follow-up ]
    Suicidal events as assessed using the C-SSRS
  • Mood symptoms [ Time Frame: Over two year follow-up ]
    As assessed using the KSADS-MRS and KSADS-DEP-P
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2013)
Cost effectiveness [ Time Frame: Over two year follow-up ]
Cost effectiveness as assessed using utilization and costs from the healthcare payer and provider system perspectives
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dialectical Behavior Therapy (DBT) for Adolescents With Bipolar Disorder
Official Title  ICMJE Dialectical Behavior Therapy (DBT) for Adolescents With Bipolar Disorder
Brief Summary Of all psychiatric diagnoses, bipolar disorder imparts the greatest risk for completed suicide in adolescence, and is further associated with poor psychosocial functioning, substance abuse and legal difficulties, and exorbitant healthcare costs exceeding those for other adolescent psychiatric conditions. Treatment guidelines indicate optimal management of pediatric bipolar disorder includes a combination of medication and psychotherapy. Yet, little is known about effective psychotherapy approaches for this population, and none expressly target suicidality. An efficacious, cost-effective psychosocial intervention for adolescents with bipolar disorder has great potential to decrease the substantial morbidity, mortality and costs associated with adolescent bipolar disorder.
Detailed Description Of all psychiatric diagnoses, bipolar disorder (BP) imparts the greatest risk for completed suicide in adolescence, and is associated with other negative outcomes including poor psychosocial functioning and substance abuse. Furthermore, healthcare costs for adolescents with BP exceed those for other adolescent psychiatric conditions. Treatment guidelines indicate optimal management of pediatric BP includes a combination of pharmacotherapy and psychotherapy. Yet, little is known about effective psychotherapy approaches for this population, and none expressly target suicidality. An efficacious, cost-effective psychotherapy for adolescents with BP has great potential to decrease the substantial morbidity, mortality and costs associated with this illness. Dialectical Behavior Therapy (DBT) is a skills-based psychotherapy originally developed for adults with borderline personality disorder. DBT holds promise for adolescents with BP given shared treatment targets including suicidality and psychosocial functioning. Our group's preliminary data on DBT for adolescents with BP provide strong support for the feasibility and acceptability of the treatment model, and indicate DBT is associated with improvement in targeted treatment domains including suicidality, emotional dysregulation, and depression, and these improvements are greater among adolescents receiving DBT as compared with standard of care (SOC) psychotherapy delivered at our Child and Adolescent Bipolar Services (CABS) specialty clinic. The proposed study aims to evaluate in a randomized controlled trial the efficacy of DBT + pharmacotherapy as compared with CABS SOC psychotherapy + pharmacotherapy over 2 year followup among adolescents (age 12-18) with BP (n=100). Primary outcome domains include suicidal events and mood symptoms. Our team includes an expert in health services cost effectiveness, enabling us to examine the cost effectiveness of DBT. Our exploratory aim is to elucidate moderators and mediators of DBT treatment response in this population. Identification of patient factors that predict response to DBT, as well as mechanisms by which DBT benefits patients, will directly inform the planful dissemination of the treatment (if shown to be effective) for those most likely to benefit. Furthermore, a supplement is enabling examination of neural mechanisms underlying DBT treatment response as assessed via fMRI at pre- and mid-treatment. These aims are in direct accord with the NIMH Strategic Plan to prioritize research on improved treatments for mental illness while also generating information regarding underlying mechanisms of disorder; facilitate widespread use of evidencebased interventions by demonstrating cost effectiveness; and systematically study elements of personalized intervention. Furthermore, this project aligns with the mission of the National Action Alliance for Suicide Prevention Research Prioritization Task Force: to prioritize gaps in the research that will reduce the rate of suicide and suicide attempts, to target particularly high-risk groups, and to move toward uptake of evidence-based interventions for suicidality.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Dialectical Behavior Therapy + Pharmacotherapy
  • Standard of Care Psychotherapy + Pharmacotherapy
Intervention  ICMJE
  • Behavioral: Dialectical Behavior Therapy
    Dialectical Behavior Therapy
  • Behavioral: Standard of Care Psychotherapy
    Standard of Care Psychotherapy
  • Drug: Pharmacotherapy
    Standard of Care Pharmacotherapy
Study Arms  ICMJE
  • Experimental: Dialectical Behavior Therapy + Pharmacotherapy
    Dialectical Behavior Therapy + Pharmacotherapy
    Interventions:
    • Behavioral: Dialectical Behavior Therapy
    • Drug: Pharmacotherapy
  • Active Comparator: Standard of Care Psychotherapy + Pharmacotherapy
    Standard of Care Psychotherapy + Pharmacotherapy
    Interventions:
    • Behavioral: Standard of Care Psychotherapy
    • Drug: Pharmacotherapy
Publications * Goldstein TR, Axelson DA, Birmaher B, Brent DA. Dialectical behavior therapy for adolescents with bipolar disorder: a 1-year open trial. J Am Acad Child Adolesc Psychiatry. 2007 Jul;46(7):820-30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 2, 2013)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria: For the proposed study, inclusion criteria are as follows: 1) age 12 years, 0 months to 18 years, 11 months; 2) a diagnosis of Bipolar Disorder (BP) I, II or NOS by the K-SADS-PL with an acute manic, mixed or depressive episode in the 3 months preceding study entry; 3) willing to engage in pharmacotherapy treatment at the CABS specialty clinic; 4) at least one parent or guardian with whom the patient lives or interacts on a significant basis (5 hours per week or more) who is willing to participate in DBT skills training; 5) English language fluency and at minimum a 3rd grade literacy level; 6) able and willing to give informed consent/assent to participate.

Exclusion Criteria: For the proposed study, exclusion criteria are as follows: 1) evidence of mental retardation, pervasive developmental disorder, or organic central nervous system disorder by the K-SADS-PL, parent report, medical history, or school records; 2) a life-threatening medical condition requiring immediate treatment; 3) current victim of sexual or physical abuse.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02003690
Other Study ID Numbers  ICMJE MH100056
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tina R Goldstein, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Tina R Goldstein, PhD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP